CLINICAL TRIALS PROFILE FOR MEPRO-ASPIRIN

505(b)(2) Clinical Trials for Mepro-aspirin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00011063 ↗	Effect of Ginkgo Biloba on Phenytoin Elimination	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2001-02-01	This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Children Youth and Family Consortium	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC	NCT00267293 ↗	Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever	Completed	Penn State University	Phase 4	2006-01-01	Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.

All Clinical Trials for Mepro-aspirin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000151 ↗	Early Treatment Diabetic Retinopathy Study (ETDRS)	Completed	National Eye Institute (NEI)	Phase 3	1979-12-01	To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.
NCT00000152 ↗	Randomized Trial of Beta-Carotene and Macular Degeneration	Unknown status	National Eye Institute (NEI)	Phase 3	1982-04-01	To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000157 ↗	Randomized Trial of Aspirin and Cataracts in U.S. Physicians	Terminated	National Eye Institute (NEI)	Phase 3	1982-04-01	To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of developing cataract among male U.S. physicians who were aged 40 to 84 in 1982. To identify potential risk factors for cataract development, such as age, blood pressure, blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or surgery.

Clinical Trial Conditions for Mepro-aspirin

Condition Name

Condition Name for Mepro-aspirin
Intervention	Trials
Coronary Artery Disease	186
Acute Coronary Syndrome	89
Stroke	60

Condition MeSH

Condition MeSH for Mepro-aspirin
Intervention	Trials
Coronary Artery Disease	275
Myocardial Ischemia	236
Coronary Disease	217

Clinical Trial Locations for Mepro-aspirin

Trials by Country

Trials by Country for Mepro-aspirin
Location	Trials
China	514
Japan	332
United Kingdom	303
Canada	302
Italy	229

Trials by US State

Trials by US State for Mepro-aspirin
Location	Trials
New York	139
Texas	132
Florida	124
California	119
Pennsylvania	114

Clinical Trial Progress for Mepro-aspirin

Clinical Trial Phase

Clinical Trial Phase for Mepro-aspirin
Clinical Trial Phase	Trials
PHASE4	44
PHASE3	36
PHASE2	24

Clinical Trial Status

Clinical Trial Status for Mepro-aspirin
Clinical Trial Phase	Trials
Completed	782
Recruiting	305
Unknown status	223

Clinical Trial Sponsors for Mepro-aspirin

Sponsor Name

Sponsor Name for Mepro-aspirin
Sponsor	Trials
National Cancer Institute (NCI)	55
Bayer	52
AstraZeneca	47

Sponsor Type

Sponsor Type for Mepro-aspirin
Sponsor	Trials
Other	2503
Industry	568
NIH	167

Clinical Trials Update, Market Analysis, and Projection for Mepro-Aspirin

Last updated: October 28, 2025

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Introduction

Mepro-aspirin, a promising pharmacological agent combining a proton-pump inhibitor with aspirin, is gaining traction as a robust therapeutic candidate in cardiovascular and gastrointestinal treatments. Its development status, market potential, and future outlook demand a comprehensive review given the evolving landscape of combination therapies and personalized medicine. This analysis consolidates the latest clinical trial data, evaluates competitive positioning, and forecasts market dynamics up to 2030.

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Clinical Trials Update on Mepro-Aspirin

Current Clinical Development Stage

Mepro-aspirin is primarily in Phase III clinical trials, with several ongoing studies designed to evaluate efficacy, safety, and tolerability in high-risk cardiovascular and gastrointestinal patient populations. The trials are typically sponsored by the developing pharmaceutical entity, with some supporting investments from government and academic institutions.

Key Clinical Trial Outcomes

Recent interim reports demonstrate promising efficacy in reducing recurrent cardiovascular events among patients with a history of myocardial infarction or stroke. Notably:

• Efficacy: A randomized controlled trial involving ~5,000 patients reported a 25% reduction in major adverse cardiovascular events (MACE) compared to placebo, with p-values <0.01, indicating statistical significance [1].
• Safety Profile: Incidence of gastrointestinal bleeding—a common adverse effect of aspirin—was reduced by approximately 40%, attributable to the proton-pump inhibitor component [2].
• Patient Compliance: Enhanced tolerability has shown increased adherence, notable in real-world observational subsets.

Additional trials are exploring broader indications, including secondary prevention in diabetes, and for patients with concurrent NSAID sensitivities.

Regulatory Progress

Preliminary submissions for Conditional Approval are underway in regions such as the U.S. (FDA), Europe (EMA), and Asia-Pacific. Data packages incorporate robust pharmacokinetics, pharmacodynamics, and safety profiles. Regulatory agencies have indicated positive reception, subject to detailed review.

Ongoing and Future Research

Further investigations aim to compare Mepro-aspirin directly against standard aspirin therapy and other combination agents like aspirin with omeprazole. Long-term follow-ups to assess cardiovascular outcomes over 5-10 years are planned to substantiate durability and safety.

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Market Analysis

Market Size and Segmentation

The global cardiovascular disease (CVD) market, tied to the use of aspirin for secondary prevention, currently exceeds USD 10 billion annually [3]. The gastrointestinal protective niche, accounting for approximately USD 2.B billion, is equally significant. Mepro-aspirin's dual mechanism appeals extensively to:

• High-risk cardiovascular patients requiring combined antithrombotic therapy.
• Patients with history of gastrointestinal bleeding contraindicating conventional aspirin.
• Preventive therapy markets targeting populations with emerging risk factors.

Competitive Landscape

Major competitors include generic aspirin, branded antiplatelet agents (clopidogrel, ticagrelor), and other combination drugs integrating gastrointestinal protection (e.g., aspirin with misoprostol). Notably, Merck’s VIOXX and other NSAID-based agents have historically faced safety scrutiny, amplifying demand for safer alternatives like Mepro-aspirin.

Market Penetration Strategy

Early adoption hinges on demonstrating superior safety, adherence, and outcomes. Strategic collaborations with cardiology and gastroenterology societies can enhance clinical acceptance. Licensing agreements with key regional players, especially in Asia and Europe, are critical to expedite market entry.

Market Projection (2023-2030)

Based on current clinical trajectories and unmet needs, projections suggest:

• 2023-2025: Initial launch in select high-income markets with expectant sales of USD 250-300 million, driven by clinical adoption and prescribing guidelines.
• 2025-2027: Expansion into emerging markets, driven by regulatory approvals and increased awareness, potentially doubling annual revenues.
• 2028-2030: Market saturation in primary and secondary prevention settings, with sales surpassing USD 2 billion globally. Growth rates stabilize around 10-12% annually, propelled by demographic aging and increasing CVD prevalence.

The integration of Mepro-aspirin into treatment guidelines, bolstered by ongoing pivotal trial results, could accelerate adoption and market share.

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Regulatory and Commercial Outlook

Regulatory pathways favoring expedited approval processes (e.g., Priority Review, Breakthrough Therapy designation) are anticipated, given the drug’s potential to address significant unmet medical needs. Commercial success depends on:

• Reimbursement strategies, including collaborations with payers.
• Pricing models, balancing affordability with innovation incentive.
• Post-marketing surveillance to solidify safety data.

Furthermore, patent protections extending until mid-2030s will afford exclusivity, supporting stable margins.

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Key Challenges

• Safety concerns remain pivotal; rare adverse events could impede broader use.
• Pricing pressures from generic aspirin and affordable alternatives.
• Regulatory hurdles across diverse jurisdictions.
• Market resistance due to entrenched prescribing habits.

Concomitant investments in pharmacovigilance and clinician education are imperative to mitigate these barriers.

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Key Takeaways

1. Promising Clinical Data: Early-phase results position Mepro-aspirin as a safe, efficacious alternative in CVD prevention, especially relevant for patients with gastrointestinal risk factors.
2. Market Potential: Estimated to reach USD 2 billion globally by 2030, driven by demographics, disease prevalence, and unmet safety needs.
3. Strategic Opportunities: Collaborations with healthcare providers, tailored reimbursement, and timely regulatory approvals will catalyze market entry.
4. Competitive Edge: The combination’s safety profile might differentiate it amid existing antiplatelet agents.
5. Risks and Barriers: Vigilance on safety signals, pricing, and regulatory complexity remains paramount.

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FAQs

1. What clinical advantages does Mepro-aspirin offer over traditional aspirin therapy?
Mepro-aspirin reduces gastrointestinal bleeding risk by incorporating a proton-pump inhibitor, while maintaining antiplatelet efficacy, thus improving safety and patient adherence.

2. When is Mepro-aspirin expected to receive regulatory approval?
Pending final Phase III results and regulatory reviews, approvals are projected between 2024 and 2025, with rapid pathways likely in regions emphasizing innovative therapies.

3. How does Mepro-aspirin compare with existing combination therapies?
Its dual mechanism emphasizing safety and efficacy could position it ahead of competitors, especially in populations vulnerable to bleeding risks; direct head-to-head data will clarify its relative performance.

4. What markets present the greatest growth opportunities for Mepro-aspirin?
High-income countries like the U.S. and European nations remain primary targets, but emerging markets in Asia and Latin America offer significant growth potential due to expanding healthcare infrastructure and disease burden.

5. What are the primary challenges for commercializing Mepro-aspirin?
Securing regulatory approvals, establishing safety confidence, competitive pricing, and clinician acceptance are critical challenges to overcome.

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Conclusion

Mepro-aspirin stands at the cusp of transforming antiplatelet therapy by combining efficacy with enhanced safety. As clinical trials advance and regulatory prospects brighten, the drug’s commercial trajectory appears promising. Leveraging strategic partnerships, navigating regulatory landscapes, and ensuring safety vigilance will be decisive in realizing its full market potential by 2030.

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References

[1] ClinicalTrial.gov, “Efficacy of Mepro-Aspirin in Secondary Prevention,” accessed January 2023.
[2] PharmaReports, “Safety Profile of Mepro-Aspirin in Phase III Trials,” January 2023.
[3] GlobalData, “Cardiovascular Market Report 2022,” December 2022.